(26 days)
No
The document describes image processing but does not mention AI, ML, or any related terms like deep learning or neural networks. The focus is on illumination and imaging modalities.
No.
The device is an imaging system used to visualize anatomical structures and physiological processes, not to treat a disease or condition.
Yes
The device provides visual assessment of vessels, blood flow, related tissue perfusion, and visualization of biliary ducts and the lymphatic system using fluorescence imaging, which are diagnostic indicators for surgeons during surgery.
No
The device description explicitly states it is a "light-generating unit" and part of an "endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an imaging system used during surgery to visualize structures within the body using visible light and near-infrared fluorescence/transillumination. It uses administered agents (indocyanine green and pafolacianine) to enhance visualization, but it is not analyzing a sample taken from the body.
- Intended Use: The intended use clearly describes surgical procedures and visualization of internal structures and blood flow.
- Device Description: The device description focuses on light generation and imaging capabilities for surgical applications.
The device is a surgical imaging system, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
780 nm L11 LED Light Source with AIM and SafeLight Cable:
Upon intravenous administration of SPY AGENTTMGREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the 780 mm L11 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
OWN, FSC, FCW, GWG
Device Description
The 780 nm L11 LED Light Source with AIM is part of the 780 nm Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The 780 nm L11 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.
Mentions image processing
The image data is processed to provide a video stream that is then sent to a display for viewing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible light, Near-infrared imaging, Near-infrared fluorescence, Near-infrared transillumination
Anatomical Site
vessels, blood flow, related tissue perfusion, major extra-hepatic bile duct, common bile duct, common hepatic duct, lymphatic system, lymphatic vessels, lymph nodes, ureter, tissues that have taken up the drug
Indicated Patient Age Range
Adults and pediatric patients aged one month and older (for visual assessment of vessels, blood flow and related tissue perfusion).
Adults and pediatric patients 12 to 17 years of age (for visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct).
Adults and pediatric patients > 6 years of age (for endonasal skull base surgery).
Adults (for minimally invasive cranial neurosurgery).
Intended User / Care Setting
Surgeons performing minimally invasive surgery, cranial neurosurgery, endonasal skull base surgery, open or laparoscopic surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance - Bench studies were conducted including: Laser Power Output, Spatial Uniformity, Minimum Detectable Fluorescence, Fluorescence Detection Depth, Clinically Meaningful Limits of Detection, Signal to noise, Dynamic Range, Localization. All tests resulted in PASS.
Software performance was in accordance with IEC 62304:2015 and resulted in PASS.
No biocompatibility testing was required as the device is not patient contacting.
No clinical studies were required to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Michelle Hughes Senior Staff Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
June 29, 2022
Re: K221611
Trade/Device Name: 780 nm L11 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: June 1, 2022 Received: June 3, 2022
Dear Michelle Hughes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R. P. Ogden, MS Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221611
Device Name 780 nm L11 LED Light Source with AIM
Indications for Use (Describe)
780 nm L11 LED Light Source with AIM and SafeLight Cable:
Upon intravenous administration of SPY AGENTTMGREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
stryker
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92.
510(k) Number : K221611
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Hughes
Senior Staff Regulatory Affairs Specialist
Email: michelle.hughes@stryker.com
Phone: (408) 754-2473 |
| Date Prepared: | June 28, 2022 |
Subject Device:
| Name of Device: | 780 nm L11 LED Light Source with AIM |
|---|---|
| Common or | |
| Usual Name | Light Source, Illuminator |
| Classification | |
| Name: | Confocal Optical Imaging1 (21 C.F.R. §876.1500) |
| Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020) | |
| Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020) | |
| Endoscope, Neurological4 (21 C.F.R. §882.1480) | |
| Regulatory Class: | II |
| Product Code: | OWN1 |
| FSC2 | |
| FCW3 | |
| GWG4 | |
| 510(k) Review | |
| Panel: | General & Plastic Surgery1 |
| Gastroenterology/ Urology2,3 | |
| Neurology4 |
IWhen used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging
2When used to transilluminate the ureter during open or laparoscopic surgical procedures
3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.
4When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial neurosurgery and endonasal skull base surgery.
Predicate Device(s):
| 780 nm L11 LED Light Source with AIM (primary predicate) | K214046 |
|---|---|
| VS3 Iridium System (reference device) | K210265 |
5
strvk
Device Description:
The 780 nm L11 LED Light Source with AIM is part of the 780 nm Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The 780 nm L11 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.
Indications for Use:
Upon intravenous administration of SPY AGENT™GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the 780 mm L11 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system. including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
6
stryker
Comparison of Technological Characteristics with the Predicate Device:
| Item | Subject Device
Predicate Devices | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| | 780 nm L11 LED Light Source
with AIM | 780 nm L11 LED Light
Source with AIM
(primary predicate) | VS3 Iridium System
(reference device) |
| Manufacturer | Stryker | Same as subject device. | Visionsense Ltd.
(Medtronic) |
| Submission
Reference | Current submission | K214046 | K210265 |
| Intended Use | Endoscopic white light and near-
infrared illumination and
imaging during endoscopic
procedures. | Same as subject device | Same as subject device |
| Indications for
Use | NOTE 1 | NOTE 2 | NOTE 3 |
| Imaging Modes | White light
Near-infrared fluorescence
Near-infrared transillumination | Same as subject device. | White light
Near-infrared fluorescence |
| Imaging Agents | SPY AGENT™ GREEN
(indocyanine green for injection,
USP)
pafolacianine | SPY AGENT™ GREEN
(indocyanine green for
injection, USP) | Indocyanine Green
pafolacianine |
| Principles of
Operation | Via an optical light guide,
endoscope and coupler, light is
projected from a light source andeither reflected or absorbed and
fluoresced onto one or more
complementary metal oxide
semiconductor image sensors
which acquire a continuous
stream of image data. The image
data is processed to provide a
video stream that is then sent to
a display for viewing. | Same as subject device. | Same as subject device. |
| System
Components | Light Source (subject of this
submission)
SafeLight Cable
Camera System
Laparoscopes
IRIS Ureteral Kit
NOTE: This represents the
components of the AIM System. | Same as subject device. | Xenon Light Source
Laser Light Source
Light Cable
Camera System
Laparoscope |
| Safety Standards | IEC 60601-1
IEC 60601-2-18
IEC 60601-1-2
IEC 60601-1-6
IEC 60825-1 | Same as subject device. | Same as subject device. |
| Laser Safety
Classification | Class 1M | Same as subject device. | Class 3R |
| Light Source/
Laser | RGB LEDs/
Infrared Laser | Same as subject device. | Xenon Bulb/
Infrared Laser |
| Maximum output | 1300-1700 mW | Same as subject device. | 500 mW |
| Item | Subject Device | Predicate Devices | |
| | 780 nm L11 LED Light Source
with AIM | 780 nm L11 LED Light
Source with AIM
(primary predicate) | VS3 Iridium System
(reference device) |
| Excitation
Wavelength(s) | Near-infrared fluorescence: 780 nm
Near-infrared transillumination:
830 nm | Same as subject device. | Near-infrared fluorescence:
785 nm |
| System
Detection
Bandwidth | IR Spectrum: 795 nm-900 nm | Same as subject device. | IR Spectrum: 800 nm-850 nm |
| System Angle of
view | 0° and 30° | Same as subject device. | Same as subject device. |
| System Field of
view | 70° - 80° | Same as subject device | 70° - 95° |
7
NOTE 1: Upon intravenous administration of SPY AGENTM GREEN (indocyanine green for injection, USP), the 780 mm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for bilization. Additionally, the 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstital administration of SPY AGENT GREEN, the 780 mm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes. Upon administration and use of patolacianne consistent with its approved label, the 780 nm L11 LED Light Source and SafeLight™ Cable is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The 700 nm L 1 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparossopic surgical procedures.
NOTE 2: Upon intravenous administration of SPY AGENTM GREEN (indocyanine green for injection, USP), the 780 mm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for bilization. Additionally, the 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstital administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymph nodes. The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
NOTE 3: Upon intravenous administration and use of an ICG consistent with its approved labeling, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography. Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-IR 785 mm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
8
Image /page/8/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and black. The letters are closely spaced together, and the overall appearance is modern and clean. The word is likely a logo or brand name.
Performance Data:
| Test | Method | Result |
|---|---|---|
| Software | In accordance with IEC 62304:2015 | PASS |
| Performance - | ||
| Bench | Laser Power Output | PASS |
| Spatial Uniformity | PASS | |
| Minimum Detectable Fluorescence | PASS | |
| Fluorescence Detection Depth | PASS | |
| Clinically Meaningful Limits of Detection | PASS | |
| Signal to noise | PASS | |
| Dynamic Range | PASS | |
| Localization | PASS |
NOTE: The 780 nm L11 LED Light Source with AlM is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence.
NOTE: The 780 nm L11 LED Light Source does not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The 780 nm L11 LED Light Source with AIM is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the 780 nm L11 LED Light Source with AIM is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate devices.